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Wide experience in

Regulatory and

quality management

Health Consulting

  • CE certification of medical devices
  • Processing of licences with healthcare authorities
  • Quality management
    system
  • Technical management
    service

The medical devices sector entails significant technologies for treating and diagnosing diseases, and for maintaining and improving patients' quality of life. This is why these products are subject to strict, complex regulations.

Bexen medical has been working in the design, development, manufacture and marketing of medical devices for 40 years, and we have solid, recognised experience in the sector's regulatory management.

Through our HEALTH CONSULTING department, we offer you the benefits of our experience and help companies in our sector to meet all their regulatory and quality obligations.

CE certification of medical devices

In order to market a medical device, you must first apply for the corresponding licence and EC declaration and/or CE marking for the product in question, according to existing legislation.

The Bexen medical technical team will advise you and process the application to obtain CE marking for your product, so that you can market it with the maximum quality and safety guarantees.

  • Identification of the body that has been notified
  • Processing of the CE marking application
  • Preparation of the technical documentation for the CE marking application
  • Support in the certification process
  • Ongoing active support

Processing of licences with healthcare authorities

  • Procedures for the licence prior to operation: acquisition, modifications, revalidation….
  • Communications related to marketing and market placement
  • Certificates of free export
  • Registering products in other countries

Quality management
system

The implementation of a Management System based on the ISO standards and subsequent certification, undoubtedly sets the company above the rest, and gives it a competitive edge.

  • ISO 13485 Quality Management System for Medical Devices
  • ISO 9001 Quality Management System
  • ISO 14001 Environmental Management System

Bexen medical has a specialised technical team that offers an integral service for implementing these Quality Management Systems:

  • Implementation
  • Certification
  • Maintenance
  • Active support

Technical management service

Companies that engage in activities related to medical devices must have a qualified Technical ManagerResponsable Técnico to ensure all regulations are met and be approved by the AEMPS [Spanish Agency of Medicines and Medical Devices].

Bexen medical offers regular technical assistance from one of our experts, to provide a Technical Managementservice, which oversees the manufacture, release and market placement of medical devices.